MAUDE Adverse Event Report: BD SUZHOU (MDS) BD SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	383346
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd saf-t-intima w/y adapter gn 18ga x 1.0in leaked it was reported by customer that when responding to a hypotension alarm on central monitoring.Upon arrival into room patient was found in a large pool of blood on her left side.Arterial line intact.A #22 piv where heparin was infusing and still connected to the piv had backflow of blood.Attempted to aspirate to assess piv howver air mixed with blood returned.D/c piv and held manual pressure.Upon further asessment of the piv, when flushed i found a leak in the j-loop attached tubing directly before the butterfly pinch area.Piv saved and given to cns.Rcc received a complaint via email.Email(s) attached.We received an incident report from one of the our units.The product is ref# 383346 safety system with y adapter.The nurse states ¿responding to a hypotension alarm on central monitoring.Upon arrival into room patient was found in a large pool of blood on her left side.Arterial line intact.A #22 piv where heparin was infusing and still connected to the piv had backflow of blood.Attempted to aspirate to assess piv howver air mixed with blood returned.D/c piv and held manual pressure.Upon further asessment of the piv, when flushed i found a leak in the j-loop attached tubing directly before the butterfly pinch area.Piv saved and given to cns.¿.
Event or Problem Description
No additional informaiton provided.
Additional Manufacturer Narrative
Dhr review: the complaint lot# is 3354739, sku is 383346, assembly in suzhou plant on 2024.Jan.9, lot quantity is (b)(4) ea.Review the in-process test record and outgoing test report, all test results meet the product specifications, no abnormal found.Review the product assembly record, no non-conformities, deviations or rework activities for this lot.Returned sample analysis: no sample returned; no picture provided.Retain sample analysis: sampling 2ea from the retain sample of the same lot to do leakage test, test result is within product specification.Refer to the attachment for retain sample test report.Possible cause analysis: based on the information, leakage is reported from tubing or wing inserter area.The possible reasons for this type of failure may including: 1.The chemical bonding performance between tubing and wing is not good, leakage is from the bonding location.2.Tubing damage/broken issue, or poor prn assembly status current manufacture already has control procedures as below to monitor and prevent this kind of defect: 1.Both in-process and outgoing sampling will check the pull force related extension tubing, including bonding force and swaging force for two ends, poor connection can be detected.2.Both in-process and outgoing sampling check do leakage test for component with extension tubing and prn connector.There is no sample returned, no picture provided, and the retain sample leakage test result is pass, so the root cause is not clear for this leakage issue.

• Brand Name: BD SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20260320
• Report Number: 3002601200-2024-00444
• Device Sequence Number: 12734035
• Product Code: FOZ
• UDI-Device Identifier: 00382903833467
• UDI-Public: (01)00382903833467(11)231220(17)271231(10)3354739
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 383346
• Device Lot Number: 3354739
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown